Psoriasis Clinical Trial

Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

Summary

This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Completed the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies.

Written informed consent form.

Key Exclusion Criteria:

A protocol deviation in either of the preceding phase III studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject.

Ongoing use of prohibited psoriasis or non-psoriasis treatments.

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL).

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1147

Study ID:

NCT01544595

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 178 Locations for this study

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Novartis Investigative Site
Birmingham Alabama, 35205, United States
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Birmingham Alabama, 35233, United States
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Phoenix Arizona, 85013, United States
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Phoenix Arizona, 85032, United States
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Los Angeles California, 90045, United States
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Oceanside California, 92056, United States
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Pasadena California, 91105, United States
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San Diego California, 92103, United States
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San Diego California, 92123, United States
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Colorado Springs Colorado, 80915, United States
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Snellville Georgia, 30078, United States
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Indianapolis Indiana, 46256, United States
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Topeka Kansas, 66606, United States
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Louisville Kentucky, 40241, United States
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Louisville Kentucky, 40291, United States
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Ann Arbor Michigan, 48109, United States
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Omaha Nebraska, 68144, United States
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New York New York, 10029, United States
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Rochester New York, 14623, United States
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High Point North Carolina, 27262, United States
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Warren Ohio, 44483, United States
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Oregon City Oregon, 97045, United States
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Portland Oregon, 97210, United States
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Portland Oregon, 97223, United States
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Duncansville Pennsylvania, 16635, United States
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Philadelphia Pennsylvania, 19104, United States
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Johnston Rhode Island, 02919, United States
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Charleston South Carolina, 29407, United States
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Kingsport Tennessee, 37660, United States
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Nashville Tennessee, 37203, United States
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Austin Texas, 78759, United States
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Dallas Texas, 75231, United States
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Dallas Texas, 75246, United States
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Houston Texas, 77030, United States
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San Antonio Texas, 78229, United States
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Salt Lake City Utah, 84117, United States
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Norfolk Virginia, 23507, United States
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Caba Buenos Aires, C1062, Argentina
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Caba Buenos Aires, C1122, Argentina
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Caba Buenos Aires, C1181, Argentina
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Caba Buenos Aires, C1425, Argentina
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Buenos Aires , C1425, Argentina
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Mendoza , M5502, Argentina
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Kogarah New South Wales, 2217, Australia
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Woolloongabba Queensland, 4102, Australia
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Carlton Victoria, 3053, Australia
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East Melbourne Victoria, 3002, Australia
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Bruxelles , 1200, Belgium
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Gent , 9000, Belgium
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Liege , 4000, Belgium
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Edmonton Alberta, T5K 1, Canada
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Surrey British Columbia, V3V 0, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Moncton New Brunswick, E1C 8, Canada
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Halifax Nova Scotia, B3H 1, Canada
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Hamilton Ontario, L8N 1, Canada
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Markham Ontario, L3P 1, Canada
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Peterborough Ontario, K9J 5, Canada
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Richmond Hil Ontario, L4B 1, Canada
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Waterloo Ontario, N2J 1, Canada
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Montreal Quebec, H3H 1, Canada
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Sainte-Foy Quebec, G1V 4, Canada
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Barranquilla Atlantico, , Colombia
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Barranquilla , , Colombia
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Bogota , 11022, Colombia
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Tallinn , 10138, Estonia
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Tallinn , 13419, Estonia
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Tartu , 51014, Estonia
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Helsinki , 00250, Finland
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Paris Cedex 10 Cedex 10, 75475, France
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Bordeaux Cedex , 33075, France
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Marseille Cedex 9 , 13913, France
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Martigues , 13500, France
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Nice Cedex 3 , 06202, France
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Reims , 51090, France
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Toulouse Cedex , 31400, France
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Koeln Nordrhein-Westfalen, 50937, Germany
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Augsburg , 86179, Germany
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Berlin , 10117, Germany
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Berlin , 10789, Germany
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Berlin , 13187, Germany
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Bielefeld , 33647, Germany
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Bochum , 44791, Germany
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Bochum , 44793, Germany
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Bonn , 53105, Germany
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Darmstadt , 64283, Germany
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Dresden , 01307, Germany
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Erfurt , 99089, Germany
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Erlangen , 91054, Germany
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Essen , 45122, Germany
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Frankfurt , 60590, Germany
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Gera , 07548, Germany
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Goettingen , 37075, Germany
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Greifswald , 17475, Germany
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Hamburg , 20354, Germany
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Hamburg , 22143, Germany
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Hamburg , 22391, Germany
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Hanau , 63450, Germany
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Heidelberg , 69115, Germany
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Kiel , 24105, Germany
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Krefeld , 47805, Germany
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Muenchen , 80802, Germany
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Muenster , 48149, Germany
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Osnabrueck , 49074, Germany
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Plauen , 08529, Germany
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Recklinghausen , 45657, Germany
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Schwerin , 19055, Germany
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Tuebingen , 72076, Germany
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Wuppertal , 42275, Germany
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Guatemala City , 01010, Guatemala
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Guatemala City , 01015, Guatemala
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Budapest , 1134, Hungary
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Debrecen , 4032, Hungary
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Kaposvar , 7400, Hungary
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Miskolc , 3529, Hungary
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Szeged , H-672, Hungary
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Szombathely , 9700, Hungary
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Kopavogur , 201, Iceland
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Afula , 18341, Israel
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Petach Tikva , 49100, Israel
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Ramat Gan , 52656, Israel
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Catania CT, 95123, Italy
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Modena MO, 41124, Italy
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Nagoya-city Aichi, 467-8, Japan
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Fukuoka-city Fukuoka, 814-0, Japan
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Kurume city Fukuoka, 830-0, Japan
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Maebashi city Gunma, 371 8, Japan
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Asahikawa-city Hokkaido, 078-8, Japan
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Sapporo-city Hokkaido, 060-0, Japan
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Kobe-City Hyogo, 654-0, Japan
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Inashiki-gun Ibaraki, 300-0, Japan
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Isehara-city Kanagawa, 259-1, Japan
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Kawasaki-city Kanagawa, 213-8, Japan
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Sagamihara-city Kanagawa, 228-8, Japan
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Kyoto-city Kyoto, 602-8, Japan
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Bunkyo ku Tokyo, 113 8, Japan
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Chiyoda-ku Tokyo, 102-8, Japan
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Minato-ku Tokyo, 105-8, Japan
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Shinagawa-ku Tokyo, 141 8, Japan
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Shinjuku-ku Tokyo, 160-0, Japan
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Shinjuku-ku Tokyo, 160-8, Japan
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Daejeon Korea, 35015, Korea, Republic of
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Seoul Korea, 05505, Korea, Republic of
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Seoul Korea, 06351, Korea, Republic of
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Seoul Seocho-gu, 06591, Korea, Republic of
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Busan , 49241, Korea, Republic of
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Gwangju , 61469, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05030, Korea, Republic of
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Seoul , 156-7, Korea, Republic of
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Daugavpils LVA, LV-54, Latvia
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Ventspils LVA, LV-36, Latvia
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Riga , 1012, Latvia
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Riga , LV-10, Latvia
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Kaunas LTU, LT-50, Lithuania
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Klaipeda LTU, 92304, Lithuania
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Vilnius , LT-07, Lithuania
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Vilnius , LT-08, Lithuania
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Lodz , 90-26, Poland
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Lodz , 90-43, Poland
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Poznan , 60 52, Poland
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Wroclaw , 50-36, Poland
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Bucuresti , 04133, Romania
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Singapore , 11907, Singapore
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Sabadell Barcelona, 08208, Spain
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Santa Coloma De Gramanet Cataluña, 08923, Spain
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Valencia Comunidad Valenciana, 46014, Spain
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Barcelona , 08041, Spain
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Madrid , 28031, Spain
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Madrid , 28041, Spain
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Malmo , SE-20, Sweden
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Uppsala , 751 8, Sweden
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Hsin Chu , , Taiwan
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Taichung , 40447, Taiwan
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Taipei , 10002, Taiwan
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Plymouth Devon, PL6 8, United Kingdom
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London England, E11 1, United Kingdom
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Salford Manchester, M6 8H, United Kingdom
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Yeovil Somerset, BA21 , United Kingdom
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Dudley West Midlands, DY1 2, United Kingdom
Novartis Investigative Site
Harrogate , HG2 7, United Kingdom
Novartis Investigative Site
Nuneaton , CV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1147

Study ID:

NCT01544595

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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